MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER.

Catalog Number 366703

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for (b)(6) with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.

Event Description

It was reported that bd vacutainer® no additive (z) tubes had foreign material in the tubes.

Manufacturer Narrative

Corrected 510(k) entry.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER.
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7491235
• MDR Text Key: 107597598
• Report Number: 1917413-2018-01259
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 366703
• Device Lot Number: 7010965
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other